Apparatus and methods for implanting a replacement heart valve

ABSTRACT

Systems and methods for docking a heart valve prosthesis. A system includes a helical anchor ( 30 ) formed as multiple coils ( 32 ) adapted to support a heart valve prosthesis ( 10 ) with coil portions ( 32 ) positioned above and below the heart valve annulus ( 12 ). A seal ( 50 ) is coupled with the helical anchor ( 30 ) and includes portions extending between adjacent coils ( 32 ) for preventing blood leakage through the helical anchor ( 30 ) and past the heart valve prosthesis ( 10 ). An expansible helical anchor ( 30 ) is formed as multiple coils ( 32 ) adapted to support a heart valve prosthesis ( 10 ). At least one of the coils ( 32 ) is normally being at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the helical anchor ( 30 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority of U.S. Provisional ApplicationSer. No. 61/864,860, filed Aug. 12, 2013; U.S. Provisional ApplicationSer. No. 61/867,287, filed Aug. 19, 2013; and U.S. ProvisionalApplication Ser. No. 61/878,280, filed Sep. 16, 2013, the disclosures ofwhich are hereby incorporated by reference herein.

TECHNICAL FIELD

The present invention generally relates to medical procedures anddevices pertaining to heart valves such as replacement techniques andapparatus. More specifically, the invention relates to the replacementof heart valves having various malformations and dysfunctions.

BACKGROUND

Complications of the mitral valve, which controls the flow of blood fromthe left atrium into the left ventricle of the human heart, have beenknown to cause fatal heart failure. In the developed world, one of themost common forms of valvular heart disease is mitral valve leak, alsoknown as mitral regurgitation, which is characterized by the abnormalleaking of blood from the left ventricle through the mitral valve andback into the left atrium. This occurs most commonly due to ischemicheart disease when the leaflets of the mitral valve no longer meet orclose properly after multiple infarctions, idiopathic and hypertensivecardiomyopathies where the left ventricle enlarges, and with leaflet andchordal abnormalities, such as those caused by a degenerative disease.

In addition to mitral regurgitation, mitral narrowing or stenosis ismost frequently the result of rheumatic disease. While this has beenvirtually eliminated in developed countries, it is still common whereliving standards are not as high.

Similar to complications of the mitral valve are complications of theaortic valve, which controls the flow of blood from the left ventricleinto the aorta. For example, many older patients develop aortic valvestenosis. Historically, the traditional treatment had been valvereplacement by a large open heart procedure. The procedure takes aconsiderable amount of time for recovery since it is so highly invasive.Fortunately, in the last decade great advances have been made inreplacing this open heart surgery procedure with a catheter procedurethat can be performed quickly without surgical incisions or the need fora heart-lung machine to support the circulation while the heart isstopped. Using catheters, valves are mounted on stents or stent-likestructures, which are compressed and delivered through blood vessels tothe heart. The stents are then expanded and the valves begin tofunction. The diseased valve is not removed, but instead it is crushedor deformed by the stent which contains the new valve. The deformedtissue serves to help anchor the new prosthetic valve.

Delivery of the valves can be accomplished from arteries which can beeasily accessed in a patient. Most commonly this is done from the groinwhere the femoral and iliac arteries can be cannulated. The shoulderregion is also used, where the subclavian and axillary arteries can alsobe accessed. Recovery from this procedure is remarkably quick.

Not all patients can be served with a pure catheter procedure. In somecases the arteries are too small to allow passage of catheters to theheart, or the arteries are too diseased or tortuous. In these cases,surgeons can make a small chest incision (thoractomy) and then placethese catheter-based devices directly into the heart. Typically, a pursestring suture is made in the apex of the left ventricle and the deliverysystem is place through the apex of the heart. The valve is thendelivered into its final position. These delivery systems can also beused to access the aortic valve from the aorta itself. Some surgeonsintroduce the aortic valve delivery system directly in the aorta at thetime of open surgery. The valves vary considerably. There is a mountingstructure that is often a form of stent. Prosthetic leaflets are carriedinside the stent on mounting and retention structure. Typically, theseleaflets are made from biologic material that is used in traditionalsurgical valves. The valve can be actual heart valve tissue from ananimal or more often the leaflets are made from pericardial tissue fromcows, pigs or horses. These leaflets are treated to reduce theirimmunogenicity and improve their durability. Many tissue processingtechniques have been developed for this purpose. In the futurebiologically engineered tissue may be used or polymers or othernon-biologic materials may be used for valve leaflets. All of these canbe incorporated into the inventions described in this disclosure.

There are in fact more patients with mitral valve disease than aorticvalve disease. In the course of the last decade many companies have beensuccessful in creating catheter or minimally invasive implantable aorticvalves, but implantation of a mitral valve is more difficult and to datethere has been no good solution. Patients would be benefited byimplanting a device by a surgical procedure employing a small incisionor by a catheter implantation such as from the groin. From the patient'spoint of view, the catheter procedure is very attractive. At this timethere is no commercially available way to replace the mitral valve witha catheter procedure. Many patients who require mitral valve replacementare elderly and an open heart procedure is painful, risky and takes timefor recovery. Some patients are not even candidates for surgery due toadvanced age and frailty. Therefore, there exists a particular need fora remotely placed mitral valve replacement device.

While previously it was thought that mitral valve replacement ratherthan valve repair was associated with a more negative long termprognosis for patients with mitral valve disease, this belief has comeinto question. It is now believed that the outcome for patients withmitral valve leak or regurgitation is almost equal whether the valve isrepaired or replaced. Furthermore, the durability of a mitral valvesurgical repair is now under question. Many patients, who have undergonerepair, redevelop a leak over several years. As many of these areelderly, a repeat intervention in an older patient is not welcomed bythe patient or the physicians.

The most prominent obstacle for catheter mitral valve replacement isretaining the valve in position. The mitral valve is subject to a largecyclic load. The pressure in the left ventricle is close to zero beforecontraction and then rises to the systolic pressure (or higher if thereis aortic stenosis) and this can be very high if the patient hassystolic hypertension. Often the load on the valve is 150 mmHg or more.Since the heart is moving as it beats, the movement and the load cancombine to dislodge a valve. Also the movement and rhythmic load canfatigue materials leading to fractures of the materials. Thus, there isa major problem associated with anchoring a valve.

Another problem with creating a catheter delivered mitral valvereplacement is size. The implant must have strong retention and leakavoidance features and it must contain a valve. Separate prostheses maycontribute to solving this problem, by placing an anchor or dock firstand then implanting the valve second. However, in this situation thepatient must remain stable between implantation of the anchor or dockand implantation of the valve. If the patient's native mitral valve isrendered non-functional by the anchor or dock, then the patient mayquickly become unstable and the operator may be forced to hastilyimplant the new valve or possibly stabilize the patient by removing theanchor or dock and abandoning the procedure.

Another problem with mitral replacement is leak around the valve, orparavalvular leak. If a good seal is not established around the valve,blood can leak back into the left atrium. This places extra load on theheart and can damage the blood as it travels in jets through sites ofleaks. Hemolysis or breakdown of red blood cells is a frequentcomplication if this occurs. Paravalvular leak was one of the commonproblems encountered when the aortic valve was first implanted on acatheter. During surgical replacement, a surgeon has a major advantagewhen replacing the valve as he or she can see a gap outside the valvesuture line and prevent or repair it. With catheter insertion, this isnot possible. Furthermore, large leaks may reduce a patient's survivaland may cause symptoms that restrict mobility and make the patientuncomfortable (e.g. short of breathe, edematous, fatigued). Therefore,devices, systems, and methods which relate to mitral valve replacementshould also incorporate means to prevent and repair leaks around thereplacement valve.

A patient's mitral valve annulus can also be quite large. When companiesdevelop surgical replacement valves, this problem is solved byrestricting the number of sizes of the actual valve produced and thenadding more fabric cuff around the margin of the valve to increase thevalve size. For example, a patient may have a 45 mm valve annulus. Inthis case, the actual prosthetic valve diameter may be 30 mm and thedifference is made up by adding a larger band of fabric cuff materialaround the prosthetic valve. However, in catheter procedures, addingmore material to a prosthetic valve is problematic since the materialmust be condensed and retained by small delivery systems. Often thismethod is very difficult and impractical, so alternative solutions arenecessary.

Since numerous valves have been developed for the aortic position, it isdesirable to avoid repeating valve development and to take advantage ofexisting valves. These valves have been very expensive to develop andbring to market, so extending their application can save considerableamounts of time and money. It would be useful then to create a mitralanchor or docking station for such a valve. An existing valve developedfor the aortic position, perhaps with some modification, could then beimplanted in the docking station. Some previously developed valves mayfit well with no modification, such as the Edwards Sapien™ valve.Others, such as the Corevalve™ may be implantable but require somemodification for an optimal engagement with the anchor and fit insidethe heart.

A number of further complications may arise from a poorly retained orpoorly positioned mitral valve replacement prosthesis. Namely, a valvecan be dislodged into the atrium or ventricle, which could be fatal fora patient. Prior prosthetic anchors have reduced the risk ofdislodgement by puncturing tissue to retain the prosthesis. However,this is a risky maneuver since the penetration must be accomplished by asharp object at a long distance, leading to a risk of perforation of theheart and patient injury.

Orientation of the mitral prosthesis is also important. The valve mustallow blood to flow easily from the atrium to the ventricle. Aprosthesis that enters at an angle may lead to poor flow, obstruction ofthe flow by the wall of the heart or a leaflet and a poor hemodynamicresult. Repeated contraction against the ventricular wall can also leadto rupture of the back wall of the heart and sudden death of thepatient.

With surgical mitral valve repair or replacement, sometimes the anteriorleaflet of the mitral valve leaflet is pushed into the area of the leftventricular outflow and this leads to poor left ventricular emptying.This syndrome is known as left ventricular tract outflow obstruction.The replacement valve itself can cause left ventricular outflow tractobstruction if it is situated close to the aortic valve.

Yet another obstacle faced when implanting a replacement mitral valve isthe need for the patient's native mitral valve to continue to functionregularly during placement of the prosthesis so that the patient canremain stable without the need for a heart-lung machine to supportcirculation.

In addition, it is desirable to provide devices and methods that can beutilized in a variety of implantation approaches. Depending on aparticular patient's anatomy and clinical situation, a medicalprofessional may wish to make a determination regarding the optimalmethod of implantation, such as inserting a replacement valve directlyinto the heart in an open procedure (open heart surgery or a minimallyinvasive surgery) or inserting a replacement valve from veins and viaarteries in a closed procedure (such as a catheter-based implantation).It is preferable to allow a medical professional a plurality ofimplantation options to choose from. For example, a medical professionalmay wish to insert a replacement valve either from the ventricle or fromthe atrial side of the mitral valve.

Therefore, the present invention provides devices and methods thataddress these and other challenges in the art.

SUMMARY

In one illustrative embodiment, a system for docking a heart valveprosthesis is provided and includes a helical anchor formed as multiplecoils adapted to support a heart valve prosthesis with coil portionspositioned above and below the heart valve annulus and a seal coupledwith the helical anchor. The seal includes portions extending betweenadjacent coils for preventing blood leakage through the helical anchorand past the heart valve prosthesis.

The system can further include a heart valve prosthesis capable of beingdelivered to a native heart valve position of a patient and expandedinside the multiple coils and into engagement with leaflets of the heartvalve. The seal is engaged with both the helical anchor and the heartvalve prosthesis. The coils of the helical anchor may be formed of asuperelastic or a shape memory material, or other suitable material. Theseal may be a membrane or panel extending over at least two coils of thehelical anchor. The membrane or panel is moved between an undeployedstate and a deployed state, the undeployed state being adapted fordelivery to a site of implantation and the deployed state being adaptedfor implanting the system and anchoring the heart valve prosthesis. Theundeployed state may be a rolled up state on one of the coils of thehelical anchor or any other collapsed state. The membrane or panel mayinclude a support element affixed therewith, such as an internal,spring-biased wire. The seal may further include one or more sealelements carried by the helical anchor with overlapping portionsconfigured to seal a space between adjacent coils of the helical anchor.The one or more seal elements may each include a support element such asan internal wire, which may be a spring-biased coil or otherconfiguration, affixed therewith. The one or more seal elements may becross sectional shape, with examples being generally circular or oblong.The one or more seal elements may each have a connecting portion affixedto one of the coils and an extension portion extending toward anadjacent coil for providing the seal function between coils.

In another illustrative embodiment a system for replacing a native heartvalve includes an expansible helical anchor formed as multiple coilsadapted to support a heart valve prosthesis. At least one of the coilsis normally defined by a first diameter, and is expandable to a second,larger diameter upon application of radial outward force from within thehelical anchor. The system further includes an expansible heart valveprosthesis capable of being delivered into the helical anchor andexpanded inside the multiple coils into engagement with the at least onecoil to move the at least one coil from the first diameter to the seconddiameter while securing the helical anchor and the heart valveprosthesis together.

As a further aspect the helical anchor may include another coil thatmoves from a larger diameter to a smaller diameter as the heart valveprosthesis is expanded inside the multiple coils. At least two adjacentcoils of the helical anchor may be spaced apart, and the adjacent coilsmove toward each other as the heart valve prosthesis is expanded insidethe multiple coils. The helical anchor may further includes a pluralityof fasteners, and the fasteners are moved from an undeployed state to adeployed state as the at least one coil moves from the first diameter tothe second, larger diameter. A seal may be coupled with the helicalanchor and include portions extending between adjacent coils forpreventing blood leakage through the helical anchor and past the heartvalve prosthesis. The system can further include at least onecompressible element on the helical anchor, the compressible elementbeing engaged by the heart valve prosthesis as the heart valveprosthesis is expanded inside the multiple coils to assist with affixingthe heart valve prosthesis to the helical anchor. The compressibleelement may take any of several forms, such as fabric or other softmaterial, or resilient, springy material such as polymer or foam. The atleast one compressible element further may include multiple compressibleelements spaced along the multiple coils or a continuous compressibleelement extending along the multiple coils. The heart valve prosthesismay further include an expansible structure including openings. Theopenings are engaged by the at least one compressible element as theheart valve prosthesis is expanded inside the multiple coils forpurposes of strengthening the connection between the anchor and theprosthesis. The multiple coils of the helical anchor may include atleast two coils that cross over each other. This system may include anyfeature or features of the system that uses the seal, and vice versa,depending on the functions and effects desired.

Methods of implanting a heart valve prosthesis in the heart of a patientare also provided. In one illustrative embodiment, the method includesdelivering a helical anchor in the form of multiple coils such that aportion of the helical anchor is above the native heart valve and aportion is below the native heart valve. The heart valve prosthesis isimplanted within the multiple coils of the helical anchor such that theheart valve prosthesis is supported by the helical anchor. A seal ispositioned between at least two adjacent coils of the helical anchor andthe heart valve prosthesis for preventing leakage of blood flow duringoperation of the heart valve prosthesis.

Positioning the seal can further comprise positioning a membrane orpanel extending over at least two coils of the helical anchor. Themethod further includes delivering the membrane or panel in anundeployed state to the site of the native heart valve and thendeploying the membrane or panel within the helical anchor, and expandingthe heart valve prosthesis against the membrane or panel. The undeployedstate includes a rolled up state or other collapsed state. Positioningthe seal may further include positioning one or more seal elementscarried by the helical anchor such that overlapping portions seal aspace between adjacent coils of the helical anchor. The one or more sealelements may each include a support element affixed therewith.

In another embodiment, a method of implanting an expansible heart valveprosthesis in the heart of a patient is provided. This method includesdelivering an expansible helical anchor in the form of multiple coilssuch that a portion of the expansible helical anchor is above the nativeheart valve and a portion is below the native heart valve. Theexpansible heart valve prosthesis is positioned within the multiplecoils of the expansible helical anchor with the expansible heart valveprosthesis and the expansible helical anchor in unexpanded states. Theexpansible heart valve prosthesis in then expanded against theexpansible helical anchor thereby securing the expansible heart valveprosthesis to the expansible helical anchor. By “expansible” it is meantthat at least one coil of the anchor enlarges in diameter.

The method may further include moving a coil from a larger diameter to asmaller diameter as the heart valve prosthesis is expanded inside themultiple coils. At least two adjacent coils of the helical anchor may bespaced apart, and the method further comprises moving the at least twoadjacent coils toward each other as the heart valve prosthesis isexpanded inside the multiple coils. The helical anchor further maycomprise a plurality of fasteners, and the method further comprisesmoving the fasteners from an undeployed state to a deployed state as theexpansible heart valve prosthesis is expanded against the expansiblehelical anchor. A seal may be positioned between adjacent coils forpreventing blood leakage through the helical anchor and past the heartvalve prosthesis and the fasteners engage the seal in the deployedstate. The fasteners may instead engage a portion of the anchor which isnot a seal. Any other aspects of the methods or systems disclosed hereinmay also or alternatively be used in this method depending on thedesired outcome.

Various additional advantages, methods, devices, systems and featureswill become more readily apparent to those of ordinary skill in the artupon review of the following detailed description of the illustrativeembodiments taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic cross-sectional view illustrating a replacementheart valve implanted in a native valve position using a helical anchor.

FIG. 1B is a schematic cross-sectional view similar to the FIG. 1A, butillustrating the use of seals in conjunction with the helical anchor.

FIG. 2A is a perspective view illustrating one method of applying theseal structure to the helical anchor.

FIG. 2B is a perspective view illustrating a further step in the methodillustrated in FIG. 2A.

FIG. 2C is a cross-sectional view showing the helical anchor afterapplication of the seal.

FIG. 2D is an enlarged cross-sectional view of the helical anchor havingone form of seal applied.

FIG. 2E is a cross-sectional view similar to FIG. 2D, but illustratingan alternative embodiment of the seal.

FIG. 2F is another enlarged cross-sectional view similar to FIG. 2E butillustrating another alternative embodiment for the seal.

FIG. 3A is a schematic perspective view illustrating another alternativeembodiment of the helical anchor and seal.

FIG. 3B is a cross-sectional view of the embodiment shown in FIG. 3A,with the helical adjacent coils compressed together for delivery.

FIG. 3C is a cross-sectional view showing the helical anchor and sealexpanded after delivery.

FIG. 3D is a partial perspective view illustrating another illustrativeembodiment of the helical anchor.

FIG. 3E is a schematic elevational view, partially fragmented, to showthe application of a seal to the helical anchor structure of FIG. 3D.

FIG. 3F is an enlarged cross-sectional view illustrating anotherembodiment of a helical coil structure with a seal.

FIG. 3G is a cross-sectional view similar to FIG. 3F, but illustratingthe structure after delivery and unfolding of the seal.

FIG. 3H is a cross-sectional view similar to FIG. 3G but illustratingmultiple parts of the helical anchor structure and associated sealexpanded after delivery.

FIG. 4A is a perspective view illustrating a helical anchor incombination with another alternative embodiment of a seal.

FIG. 4B is a perspective view of the seal illustrating an alternativeembodiment which adds support structure to the seal.

FIG. 4C is a schematic cross-sectional view illustrating the embodimentof FIG. 4A implanted in a native heart valve position.

FIG. 4D is a schematic cross-sectional view illustrating a replacementheart valve implanted within the helical anchor and seal structure ofFIG. 4C.

FIG. 5A is a perspective view of a helical anchor with a membrane orpanel seal being applied.

FIG. 5B is a perspective view of the helical anchor with the membrane orpanel seal of FIG. 5A deployed or unfolded.

FIG. 5C illustrates a perspective view of the membrane or panel sealwith an internal support structure.

FIG. 5D is an enlarged cross-sectional view of the helical coil andundeployed membrane seal.

FIG. 5E is a cross-sectional view similar to FIG. 5D but illustrating amembrane seal which has been collapsed or folded rather than woundaround a coil of the helix.

FIG. 5F is a perspective view of a portion of the coil and membrane sealillustrating further details including the internal support structureand a suture line.

FIG. 5G is a cross-sectional view illustrating the helical coil andmembrane seal implanted at a native heart valve site.

FIG. 5H is a cross-sectional view similar to FIG. 5G, but furtherillustrating a replacement or prosthetic heart valve implanted withinthe helical coil and membrane seal.

FIG. 6A is a cross-sectional view illustrating a helical coil implantedand at a native heart valve site being expanded by a balloon.

FIG. 6B is a cross-sectional view illustrating a stented, replacement orprosthetic heart valve implanted within a helical coil and membrane sealstructure.

FIG. 7A is a cross-sectional view schematically illustrating a helicalanchor having approximately two turns or coils having a first diameterand another coil having a second, larger diameter.

FIG. 7B illustrates an initial step during implantation of the helicalanchor shown in FIG. 7A at a native heart valve site with a stentmounted replacement heart valve ready for implantation within thehelical anchor.

FIG. 7C illustrates a further portion of the procedure in which thestented replacement heart valve is expanded using a balloon catheter.

FIG. 7D is a further portion of the procedure and illustrates across-sectional view of the implanted replacement heart valve within thehelical anchor.

FIG. 7D-1 is a cross-sectional view of an implanted replacement heartvalve within a helical anchor, similar to FIG. 7D but illustratingalternative configurations for the replacement heart valve and theanchor.

FIG. 8A is an elevational view of another embodiment of a helical anchorbeing expanded by a balloon catheter.

FIG. 8B is a view similar to FIG. 8A, but illustrating further expansionof the balloon catheter.

FIG. 8C is a view similar to FIG. 8B but illustrating even furtherexpansion of the balloon catheter.

FIG. 8D is an enlarged cross-sectional view showing compression of thehelical coils from FIG. 8C.

FIG. 9A is an elevational view of another embodiment of a helical anchorbeing expanded by a balloon catheter.

FIG. 9B is a view similar to FIG. 9A, but illustrating further expansionof the balloon catheter.

FIG. 9C is a view similar to FIG. 9B but illustrating even furtherexpansion of the balloon catheter.

FIG. 9D is an enlarged cross-sectional view showing compression of thehelical coils from FIG. 9C.

FIG. 10A is a partial cross-sectional view illustrating anotherembodiment of a helical anchor inserted or implanted at a native heartvalve site and insertion of a stent mounted replacement heart valvewithin the helical anchor and native heart valve site.

FIG. 10B is a cross-sectional view similar to FIG. 10A, but illustratingexpansion and implantation of the stent mounted replacement heart valvewithin the helical anchor.

FIG. 10C is a cross-sectional view, partially fragmented, of theimplanted replacement heart valve and helical anchor shown in FIG. 10B.

FIG. 10C-1 is an enlarged cross-sectional view showing engagementbetween the stent of the replacement heart valve and the helical anchor.

FIG. 10D is a top view illustrating the process of expanding the stentmounted replacement heart valve within the helical anchor of FIG. 10C.

FIG. 10E is a top view similar to FIG. 10D, but illustrating fullexpansion and implantation of the stent mounted replacement heart valve.

FIG. 11A is a partial cross-sectional view illustrating anotherembodiment of a helical anchor inserted or implanted at a native heartvalve site and insertion of a stent mounted replacement heart valvewithin the helical anchor and native heart valve site.

FIG. 11B is a cross-sectional view similar to FIG. 11A, but illustratingexpansion and implantation of the stent mounted replacement heart valvewithin the helical anchor.

FIG. 11C is a top view illustrating the process of expanding the stentmounted replacement heart valve within the helical anchor of FIG. 11B.

FIG. 11D is a top view illustrating full expansion of the stent mountedreplacement heart valve within the helical anchor of FIG. 11C.

FIG. 12A is an elevational view of another embodiment of a helicalanchor.

FIG. 12B is a cross-sectional view of another embodiment of a helicalanchor.

FIG. 12C is an enlarged cross-sectional view of the helical anchor takenalong line 12C-12C of FIG. 12B.

FIG. 12D is a top view of a helical anchor schematically illustratingexpansion by a balloon catheter.

FIG. 12E is a cross-sectional view of the helical anchor shown in FIG.12D, but expanded to show deployment of the parts into the fabric seal.

FIG. 13A is an elevational view of another embodiment of a helicalanchor.

FIG. 13B is a cross-sectional view of another embodiment of a helicalanchor.

FIG. 13C is an enlarged cross-sectional view of the helical anchor takenalong line 13C-13C of FIG. 13B with deployment of the barbs into theouter seal layer.

FIG. 14A is a perspective view of an alternative helical anchor.

FIG. 14B is a top perspective view of the helical anchor shown in FIG.14A.

FIG. 14C is a front view of the helical anchor shown in FIGS. 14A and14B.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

It will be appreciated that like reference numerals are used to refer togenerally like structure or features in each of the drawings.Differences between such elements will generally be described, asneeded, but the same structure need not be described repeatedly for eachfigure as prior description may be referred to instead for purposes ofclarity and conciseness. FIG. 1 schematically illustrates a typicalreplacement heart valve or prosthesis 10 that may be implanted in theposition of a native heart valve, such as the mitral valve 12, using acatheter (not shown). A sealed condition is desired around the valve 10,i.e., between the periphery of the replacement valve 10 and the nativebiologic tissue, in order to prevent leakage of blood around theperiphery of the replacement valve 10 as the leaflets 14, 16 of thereplacement valve 10 open and close during systolic and biastolyicphases of the heart. The portion of the replacement heart valve 10intended to be positioned in contact with native tissue includes afabric or polymeric covering 18 to prevent regurgitation of blood flow.In FIG. 1A, the fabric cover 18 is shown adjacent to the replacementvalve leaflets 14, 16 within the stent mounted replacement valve 10.These replacement valve leaflets 14, 16 are typically formed frombiologic material, such as from a cow or a pig, but may synthetic orother bioforms. Approximately half of this replacement valve 10 has noseal, i.e., it is more or less exposed stent 24 with openings 24 a. Thisis because when the replacement valve 10 is placed in the aortic nativeposition, the coronary arteries arise just above the aortic valve. Ifthe seal 18 extended the entire length of the stent portion 24 of thereplacement valve 10, the coronary artery could be blocked. In FIG. 1A,an unmodified aortic replacement valve 10 is shown implanted in ahelical anchor 30 comprised of coils 32. Leakage of blood flow may occuras depicted schematically by the arrows 36, because there is a gapbetween the seal 18 on the stented valve 10 and the attachment to thepatient's mitral valve 12. The leakage of blood flow may occur in anydirection. Here, the arrows 36 depict the leak occurring from theventricle 40 to the atrium 42 since the ventricular pressure is higherthan the atrial pressure. An unmodified aortic valve 10 placed in thenative mitral valve position will be prone to develop a leak. To avoidthis problem, two major approaches may be taken. First, a seal may beadded to the system, for example, the helical anchor 30 may have sealingfeatures added. Second, the location where the stent mounted replacementheart valve 10 sits may be changed. In this regard, if the replacementheart valve 10 is positioned lower inside the ventricle 40, the seal 18on the replacement heart valve 10 will be situated such that there is noleak. One drawback to seating the valve 10 lower inside the leftventricle 40 is that the replacement heart 10 valve may cause damageinside the left ventricle 40 or the valve 10 may obstruct ventricularcontraction. The replacement heart valve 10 may damage the ventricularwall or block the outflow of blood from the ventricle 40 into the aorta.Rather than simply seating the replacement heart valve 10 more deeply orlower into the left ventricle 40, it may be useful to keep the positionof the stent mounted replacement valve 10 more atrially positioned as itis depicted in FIG. 1A (i.e., positioned higher and extending into theatrium 42).

FIG. 1B illustrates one embodiment of providing seal structure 50 at theupper portion of a replacement heart valve 10 to prevent blood flowleakage as discussed above and shown in FIG. 1A. In this regard, one ormore seals 52 have been added to the helical anchor 30. Specifically, afabric covered oval seal structure 52 is added to the helical anchor 30to provide a seal. The seal 52 may be formed from fabric, or any othermaterial that provides a sufficient seal and does not allow blood toflow through. The seal 52 extends down to the level of the attachmentbetween the stent mounted replacement valve 10 and the native mitralleaflets 12 a, 12 b. The seal 52, in this illustrative embodiment is acontinuous tube and comprises one or more seal elements or portions 52a, 52 b, 52 c in the form of overlapping segments of fabric or othersealing material. These segments 52 a, 52 b, 52 c of sealing structureact as siding structure or shingles to seal the space between the coils32 or turns of the helical anchor 30.

FIG. 2A illustrates one manner of applying the overlapping sealstructure 50 such as shown in FIG. 1B or otherwise integrating the sealstructure 50 on the helical anchor 30. In this regard, the sealstructure 50 may be integrated with the helical anchor 30 for deliverypurposes. The shingles or overlapping seal portions 52 a-c (FIG. 1B) maybe collapsed and extruded from a catheter 60. Alternatively, once thehelical anchor 30 has been delivered to the native heart valve site, thefabric or other seal structure 50 may be delivered over the coils 32 ofthe anchor 30 from the same delivery catheter 60. Alternatively, theoverlapping seal structure 50 may be added to the helical anchor 30 asthe helical anchor 30 is being extruded or extended from the deliverycatheter 60. FIG. 2A specifically illustrates a helical anchor 30 with afabric or other seal structure 50 being fed over the helical coils 32from a sheath or delivery catheter 60. The seal structure 50 may begenerally circular in cross section or any other shape, such as a shapethat is better configured for overlapping as generally shown in FIG. 1Babove. FIG. 2B illustrates fabric 62 and an internal support coil 64being added to the helical anchor 30 in a further portion or step of theprocedure illustrated in FIG. 2A. FIG. 2C illustrates one embodiment ofa completed assembly, shown in cross section, comprising the helicalanchor 30 covered by the coil 64 and fabric 62 and delivered by a sheathor delivery catheter 60. The delivery sheath or catheter 60 may remainover the coil and fabric combination or it may be used to merely deliverthese sealing elements 62, 64 over the helical anchor 30.

FIG. 2D illustrates a cross sectional view of the sealing elements 62,64 which, in this case, are circular in cross section. These sealingelements 62, 64, including, for example, a coil support and fabriccombination, may be virtually any shape as long as they provide a sealwhen placed together. Sealing elements 62, 64 may not overlap in use butinstead contact each other as shown to create a seal therebetween.

FIG. 2E shows an oblong or oval cross sectionally shaped seal structure70 similar to the seal 50 shown in FIG. 1B in which segments 70 a, 70 boverlap each other to produce a secure and fluidtight seal. It ispossible to have the oblong seal structure 70 compressed for deliveryand then spring or bias open once the seal structure 70 is extruded froma delivery catheter or sheath. A coil 74 internally supporting fabric 72may be made of Nitinol (superelastic) wire or spring steel wire so thatit may be collapsed and then bias or spring into a predetermined shapeas needed.

FIG. 2F shows another alternative seal structure 80. In this case, asealing fabric 82 or other material is wrapped around the helical anchor30. The fabric is stitched together with suitable thread to form stiff,structural panels 84 extending from the connecting portion 86 that isaffixed to a coil 32 of the helical anchor 30. The panels 84 againoverlap, similar to a shingle effect, to provide a fluidtight seal. Thisconfiguration may be delivered in a similar manner to the previouslydescribed fabric covered coil designs above by passing the panelstructure over the helical anchor 30 as shown.

FIG. 3A illustrates another embodiment for providing a sealingstructure. In order to provide further shape and support to a sealstructure 90, there may be two or more “framing” segments 92, 94 insidea fabric covering 96 or other material seal. This will give a shape tothe seal structure 90 and provide for more reliable overlap of the sealsegments (only one shown in FIG. 3A). This may be achieved by using adouble helix in which two wires 92, 94 run parallel to each other toform a helical shape. The two wires 92, 94 may be connected at theirends with a curved section 98 as shown in FIG. 3A. The fabric or othermaterial sleeve or coating 96 may be passed over the double helix duringor after delivery of this helical seal structure 90.

FIG. 3B illustrates a cross sectional view of the seal structure 90compressed with wires 92, 94 inside the outer fabric or other material96. This can provide for easier delivery to the site of implantation.

FIG. 3C illustrates the double helix seal 90 spread apart andoverlapping after delivery. Two segments 90 a, 90 b of the helical seal90 can expand as they are being delivered to form overlapping sealsegments 90 a, 90 b similar to the “shingle” configuration discussedabove. Here, two overlapping seal segments 90 a, 90 b are supported bytwo double helix frames 92, 94 positioned adjacent and overlapping toeach other to produce an effective, fluidtight seal.

FIG. 3D illustrates another alternative method for coupling framesegments 92, 94 of a seal and, specifically, biasing the frame segments92, 94 apart. Interconnecting segments 100 between the two frame partsor wires 92, 94 can push the frame segments 92, 94 into a desired finalshape. This double helix design may be made from multiple wire pieces ormay be made from a single solid Nitinol or steel tube or wire, similarto stent manufacture techniques. The seal frame 92, 94 may also have asinusoidal or generally back and forth configuration (not shown) to holda shingle-type shape rather than two rails or wires inside of the outerseal material or fabric 96 (FIG. 3C).

FIG. 3E details how the outer seal material or fabric 96 may be placedover the expanded frame 92, 94. The seal material 96 may be preattachedto the double helix frame 92, 94 and the two may be delivered together.Alternatively, the seal material 96 may be delivered onto the doublehelix frame 92, 94 after the double helix frame 92, 94 is already inplace at the implantation site, such as the site of a native mitralvalve. In the unexpanded state, the double helix 92, 94 may be extrudedthrough a catheter as previously described.

FIGS. 3F, 3G and 3H generally show the progression of delivery andimplantation of the seal 90. In these figures, the seal material orfabric 96 extends beyond the frame 92, 94 to form flaps or panels 102 ofseal material. These flaps or panels 102 may be stiffened and reinforcedwith heavy suture, or the material may be soaked or coated in astiffening agent. This may be useful to ensure a fluidtight seal. InFIG. 3F, the internal wire frame 92, 94 is collapsed and the fabriccover 96, 102 is folded within a delivery sheath 60 for delivery. InFIG. 3G the frame 92, 94 has been delivered and the segments or flaps102 of seal material 96 that extend beyond the frame 92, 94 haveunfolded. FIG. 3H illustrates the frame parts 92, 94 expanded, in amanner similar to a stent. This provides a solid and secure seal. Thecross members or biasing members 100 that were collapsed inside thedouble helix frame 92, 94 are now biased outward and lengthened orstraightened. These cross members 100 may be made of Nitinol or otherspring material and expand the frame 92, 94 with a spring force as theframe 92, 94 is delivered from a catheter or sheath 60. Alternatively,there may be another mechanism or manner for activating and expandingthe frame 92, 94 as needed during the implantation procedure.

FIG. 4A illustrates another embodiment for adding sealing features to ahelical anchor 30. Here, a fabric windsock-type shape or panel/membranestructure 110 has been mounted to an upper turn or coil 32 of thehelical anchor 30. This panel 110 unfolds or extends within the helicalanchor 30 to provide a sealing membrane. The fabric or other sealmaterial may be sewed or permanently fastened to the helical anchor 30.Alternatively, this seal panel 110 may be delivered onto the helicalanchor 30 after the helical anchor 30 is placed at the site ofimplantation within a native heart valve. The seal material 110 may beattached on any portion of the helical anchor 30 at any level of theanchor 30. In FIG. 4A, the seal panel 110 is attached to the uppermostcoil 32 of the helical anchor 30 such that the panel 110 can then expandto the full length of the helical anchor 30 and provide a full length,fluidtight seal.

FIG. 4B illustrates the seal panel 110 opened and an internal supportstructure 112, in the form of a wire or sinusoidal-type support elementinside or within layers of the seal material. This support structure 112for the seal 110 may be made of, for example, Nitinol or steel. Thesupport 112 may be sewn into the fabric or otherwise secured to the sealmaterial. The fabric may, for example, contain a channel for the support112 and the support 112 could be pushed into the channel, expanding theseal material 110 as needed. If the support 112 is made from Nitinol orsuperelastic material, and imbedded inside the fabric or seal material110, it may straighten and fold up the fabric or other seal materialinside a delivery catheter or sheath. While being delivered, the Nitinolor superelastic support would return to its initial zigzag or sinusoidalshape, expanding the fabric as it is released and extruded from thedelivery sheath or catheter.

FIG. 4C is a cross sectional view illustrating a helical anchor 30 andfabric seal panel 110, such as shown in FIG. 4A delivered and implantedat a native valve site, such as within the mitral valve 12 of a patient.The seal panel 110 is annular in shape and generally follows theinterior of the helical anchor 30. As shown here, the fabric panel 110is stitched to the upper turn or coil 32 of the helical anchor 30 andthe fabric is folded on itself and stitched together as shown. Stitching114 can also provide structural support to help the fabric shape itselfcorrectly. The stitching may be made of steel wire or Nitinol wire thatmay assist in providing shape stability to the membrane or panelstructure 110. The stitching 114 may also be suture or thread. Theheavier the stitching material, the more support it will provide for thefabric. Here, the stitching is in horizontal lines, however, it mayinstead be other configurations such as vertical, zigzag, or any othersuitable configuration.

FIG. 4D illustrates a stent mounted heart valve 10 expanded within thehelical anchor 30 and seal structure 110 of FIG. 4C. The seal 110prevents any leakage of blood around the valve 10 and covers any areasof the stent portion 24 of the valve 10 that are not already covered andsealed. The seal 110 allows the replacement heart valve 10 to be seatedhigher toward the atrium 42, thereby reducing the risk of left ventricleinjury or left ventricle blood outflow obstruction.

FIG. 5A illustrates a helical anchor 30 with an attached membrane orpanel seal 110 being delivered onto the coils 32 of the helical anchor30. It should also be noted that the membrane or panel seal 110 can alsoimprove the attachment of the replacement heart valve 10. In thisregard, a bare helical anchor 30, particularly one made of metal thatattaches to a metal stent will result in metal surfaces contacting eachother. As the heart beats and pressure rises with each contraction,e.g., about 100,000 times per day, there is a risk of slippage betweenthe metal surfaces and potential valve dislodgement. Therefore, theaddition of a membrane, panel 110 or other seal structure can reduce thetendency for the valves to slip and even fail. The membrane or sealpanel 110 may be smooth or have various degrees of texture or roughnessto help maintain fixation of the replacement heart valve 10. Textured orroughened surfaces will increase friction and therefore reduce slippage.Also, the fabric or other seal material 110 may be forced inside theopenings or cells of the stent portion 24 of the replacement heart valve10 thereby improving or creating a locking effect and anchoring thestent mounted replacement valve 10 to the helical anchor 30, includingthe seal material 110. In FIG. 5A, the membrane or panel seal 110 isattached to the helical anchor 30 and as previously described, themembrane or panel seal 110 may be attached prior to implantation withinthe patient or added at any point during the implantation procedure. Itmay be advantageous to add the membrane or panel seal 110 after thehelical anchor 30 is placed at the implantation site in order to reducecomplication during delivery of the helical anchor 30. FIG. 5Billustrates the membrane seal or panel seal 110 unfolded or expandedwithin the helical anchor 30. As previously described, the membrane orpanel seal 110 is attached to the uppermost turn 32 of the helicalanchor 30, however, it may be attached anywhere along the helical anchor30. The membrane or panel seal 110 may be continuous or intermittent,and may be comprised of overlapping panel portions similar to a shingleeffect. Although the membrane or panel seal 110 makes a complete annulusas shown in FIG. 5B within the helical anchor 30, it may instead beformed as less than a complete annulus.

FIG. 5C is similar to FIG. 4B described above and simply illustratesthat in this embodiment, the delivered and deployed membrane seal 110may also include a similar internal support 116. It is also possiblethat the membrane or panel seal 110 is intrinsically stiff and springsopen without internal support structure of any sort. Many other ways toopen or deploy the membrane or panel seal 110 may used instead. Forexample, the panel seal 110 may contain pillars or other supports (notshown) that are collapsed for delivery but that allow the membrane orpanel 110 to be biased open once the membrane or panel 110 is deliveredfrom a suitable catheter or sheath. These pillars or other supports may,for example, be formed from shape memory or superelastic material, orother suitable spring biased material.

FIG. 5D illustrates the panel seal 110 unwinding or being deployed. Thepanel seal 110, in this illustrative embodiment, is formed of two layerswith a support 116 between these two layers. The support 116, asdescribed above, is suitably secured between the layers of the panelseal 110. Although shown as a sinusoidal configuration, the support 116may be of any desired and suitable configuration, or may be comprised ofseparate support structures such as generally circular or oval supportstructures (not shown). Other useful structures in this regard mayinclude any of those shown and described in U.S. Provisional PatentApplication Ser. No. 61/864,860, filed on Aug. 12, 2013, the disclosureof which is hereby fully incorporated by reference herein. Finally,drawstrings (not shown) may be added to the end of the membrane seal 110or to any part or parts of the membrane seal 110 that may be used topull the membrane seal 110 open and unfold it or otherwise deploy it.

FIG. 5E illustrates a membrane or panel seal 100 which has beencollapsed or folded onto itself rather than wound around the coil 32 ofthe helical anchor 30. A collapsed membrane seal 110 such as this may bemore practical. The membrane or panel seal 110 can be opened with thesupport structure 116 normally biased to a deployed state as shownpreviously, or it may be deployed by containing structural supportelements 116, such as shape memory support elements. As also previouslydiscussed, drawstrings (not shown) might be added for deploymentpurposes.

FIG. 5F illustrates a cross sectional, enlarged view of the helicalanchor 30 with the seal membrane 110 or panel extending adjacent tocoils 32 of the helical anchor 30. The panel seal 110 includes a sutureline 118 that keeps the seal 110 in place within the helical anchor 30,shown as a dotted line. This need not be a suture, instead, thesecurement may be provided by any suitable fasteners, glue, or otherelements that maintain the membrane or panel seal 110 in position. Inaddition, the panel seal 110 may be glued or attached to the helicalanchor 30 and this would eliminate the need for sutures or separatefasteners. As described previously, the panel seal 110 may be fabric orany other suitable biocompatible material. For example, the sealmaterial in this and any other embodiment may be Dacron or Goretex, ormay be biologic material from an animal or human. Other examples of sealmaterial include engineered biomaterials or any combination of biologicand/or synthetic materials. The panel seal 110, in this embodiment, isopened with a spring biased support wire 116 as generally describedabove, but may be opened in any suitable manner during or afterdeployment and implantation of the helical anchor 30.

FIG. 5G illustrates the helical anchor 30 and panel seal 110 combinationimplanted at the site of a native mitral valve 12 of a patient. FIG. 5Hillustrates a replacement heart valve 10, and specifically a stentmounted replacement heart valve 10 secured within the helical anchor 30and panel seal 110 combination. These figures are described above withregard to FIGS. 4C and 4D. Thus, it will be appreciated that the panelseal structure 110 and helical anchor 30, regardless of deployment anddelivery techniques, provide fluidtight sealing as previously described.It will be appreciated that additional features may be used to helpdeploy the panel seal or membrane 110 open as shown in FIGS. 5G and 5H.A foam layer (not shown) may also be positioned at any desired location,for example, to aid in sealing and/or valve retention. The membrane orpanel seal 110 may extend the full length of the helical anchor 30 oronly a portion of the length. In these figures, FIG. 5G illustrates themembrane or panel 110 extending only part of the length while FIG. 5Hillustrates the panel or membrane 110 extending almost the entire lengthof the valve 10. As shown in FIG. 5H, the replacement heart valve 10 ispositioned within the native mitral valve 12 such that much of thereplacement heart valve 10 sits within the atrium. It will beappreciated that the replacement heart valve 10 may be positionedanywhere along the helical anchor 30. The helical anchor 30 may containthe entire prosthetic or replacement heart valve 10 or the replacementheart valve 10 may project at either end of the helical anchor 30 orfrom both ends of the helical anchor 30. The number of coils or turns 32of the helical anchor 30 may also be varied. The key arrangement is toprevent as much leakage as possible, and maintain the replacement heartvalve 10 securely in position after implantation.

In FIG. 5H one coil 32 of the anchor 30 extends beyond the stentedprosthetic valve 10 inside the left ventricle 40. This may serve anumber of functions. The end of the stent valve 10 is sharp and maydamage structures inside the left ventricle 40. By leaving a turn 32 ofthe anchor 30 beyond the end of the valve 10, it may be possible toprotect the structures inside the heart from contacting the sharp end ofthe valve 10. The lowest turn 32 of the anchor 30 may act as a “bumper”that is smooth and prevents injury to structures inside the ventricle40. A smooth metallic (such as Nitinol) anchor coil 32 may be very welltolerated and prevent wear and abrasion inside the left ventricle 40.

The lowest turn or coil 32 of the anchor 30 may also wrap native mitralvalve leaflet tissue around the end of the valve 10. This may alsoshield the sharp end of the prosthetic valve 10 from structures insidethe heart.

The lowest turn or coil 32 of the helical anchor 30 may also providetension on chordal structures. The function of the left ventricle 40 isimproved and the shape of the left ventricle 40 can be optimized byplacing tension on chordal structures. In FIG. 5H, the lowest coil 32pulls the chordae toward the center of the ventricle 40 and shapes theleft ventricle 40 optimally for contraction. It may be useful to havemultiple coils 32 of the anchor 30 extending inside the left ventricle40 beyond the anchor 30. These coils 32 could pull the chordae inwardover a longer distance inside the heart. For example, if a patient had avery large left ventricle 40, it may be desirable to improve his leftventricular function by having a helical extension well beyond the valve10. This would tighten the chordae and reshape the left ventricle 40.The coils 32 of the anchor 30 could also be heavier/thicker diameter toassist in reshaping the heart. The diameter of the coils 32 could alsobe varied to optimize the left ventricle shape change.

The concept of reshaping the left ventricle 40 with the anchor 30 doesnot need to apply to just mitral valve replacement. The helical anchors30 shown in these descriptions can also be used for mitral valve repair.Extensions of the helix coils 32 inside the left ventricle 40 can alsore-shape the left ventricle 40 even when a replacement prosthetic valve10 is not used. As described previously, various numbers of coils 32,diameter of coils 32, thickness of materials, etc. could be used toachieve an optimal result.

It is also useful to use the helical anchor 30 to repair a native heartvalve 12 and reshape the left ventricle 40 and leave open thepossibility to add a prosthetic replacement valve 10 later if the repairfails over time. After surgical valve repair, this is not uncommon. Ananchor 30 that serves as a repair device with or without leftventricular reshaping with coils 32 that extend into the left ventricle40 may be useful as an anchor 30 if a prosthetic valve replacement isneeded later.

FIG. 6A illustrates a helical anchor 30 implanted at the native mitralvalve position. In general, it will be important to seat the helicalanchor 30 close to the under surface of the native mitral valve 12. Ifthe diameter of the coils 32 or turns under the mitral valve 12 isrelatively small, the helical anchor 30 is forced to slip down into theleft ventricle 40. The helical anchor 30 attachment to the native valve12 will be away from the annulus 12 c and once the heart starts beating,the helical anchor 30 will be sitting inside the left ventricle 40 and,when there is mitral valve tissue between the helical anchor 30 and themitral valve annulus 12 c, the helical anchor 30 is not firmly attachedin the annular region of the mitral valve 12, but rather to the leaflets12 a, 12 b lower in the left ventricle 40, and this is not desirable. InFIG. 6A, a relatively large diameter turn or coil 32 of the helicalanchor 30 is positioned just under the mitral valve leaflets 12 a, 12 b.This position is directly adjacent to the native mitral valve annulus 12c. Relatively smaller diameter coils 32 are positioned lower in the leftventricle 40. It may be useful to have a gap 120 between the relativelarger coil 32 that is positioned under the valve leaflets 12 a, 12 b atthe valve annulus 12 c and the relatively smaller coil 32 positionedfarther into the left ventricle 40. This will prevent the entire helicalanchor 30 from being pulled down farther into the left ventricle 40after implantation. Relatively smaller diameter coils 32 of the helicalanchor 30 are positioned above the mitral valve 12, i.e., above themitral valve native leaflets 12 a, 12 b. For illustrative purposes, aballoon 122 is shown for purposes of expanding the smaller diametercoils 32. This causes the larger diameter coil portions 32 to moverelatively inward in a radial direction thereby tightening all of thecoils 32 along a more similar diameter and tightening the connectionbetween the helical anchor 30 and the native mitral valve tissue. Mostimportantly, the coil or turn 32 under the native mitral valve leaflets12 a 12 b tends to grip against the underside of the mitral annulus 12 cand pull the annulus radially inward, reducing the diameter of thenative mitral annulus 12 c. Annular reduction in this manner isimportant to improve left ventricular function when the heart isenlarged. Annular diameter reduction of a native mitral valve 12 is alsoimportant during mitral valve repair. The smaller diameter annulus addsto the improvement in left ventricular function. The concept of annularreduction using a sliding helical anchor 30 to control the leaflets 12a, 12 b and pull the native mitral leaflets 12 a, 12 b and annulus 12 cradially inward is specifically useful in mitral valve repair. Theconcepts, methods and devices for improving left ventricular function inmitral valve prosthetic replacement, i.e., replacements that reduce theannulus diameter and tension chordae and reshape the left ventricle 40,will be invoked herein demonstrating mitral repair devices, concepts andmethods. A smooth turn or coil 32 of the helical anchor 30 under thenative mitral annulus 12 will have less tendency to grip against themitral valve tissue and reduce the mitral valve annulus diameter. It maybe useful to increase the “grip” of the turn or coil 32 under theannulus 12 c for this reason. This may be accomplished in many waysincluding roughening the surface of the coil 32 such as by texturing themetal or by adding a high friction coating or fabric. The coating,fabric or other high friction material may be fixed to the helicalanchor 30 or it may slide along the helical anchor 30. The high frictionportion of the helical anchor 30 may be continuous or discontinuous.

FIG. 6B illustrates the final position of the prosthetic replacementheart valve 10 inside the helical anchor 30 and its relation to thenative mitral valve 12 and left ventricle structures. The left ventriclechordate 130 have been tensioned and, therefore, the left ventricle 40has been appropriately reshaped. The sharp end 132 of the prostheticreplacement heart valve 10 has been covered by seal material 134, nativevalve tissue 136 and a “bumper” 138 of a lowest turn or coil 32 of thehelical anchor 30. This provides multiple types of protection frominjury inside the left ventricle 40 due to the sharp end of the stentedprosthetic valve 10. Also note that the stented prosthetic heart valve10 is positioned higher toward the atrium 42, and away from thestructure in the left ventricle 40. This provides further protectionfrom injury to the left ventricle 40 by the replacement heart valve 10.The fabric membrane seal, or other type of panel seal 110, may extendfor any length. In this illustration it extends beyond the replacementheart valve 10. The fabric or other seal material may also extend beyondthe end of the helical anchor 30 within the left ventricle 40. Thefabric or other seal material 110 should cover the end of thereplacement heart valve 10 until there is a seal at the level of themitral valve 12. There is no need for a seal if the prostheticreplacement valve 10 has an attached seal or a seal is otherwiseattached to the prosthetic replacement valve 10. In this case, usefulfeatures disclosed relate mainly to the attachment of the replacementvalve 10 to the helical anchor 30 and the ability of the helical anchor30 to reshape the left ventricle 40.

FIGS. 7A-7D illustrates devices, methods and procedures relating to theinteraction of the helical anchor 30, helical anchor design features andthe stent mounted replacement heart valve 10 delivered or mounted on aballoon 140. Various catheters may be manipulated to take advantage of adesign of the helical anchor 30 to improve valve implantation. Forexample, the stent mounted replacement valve 10 may be partiallydeployed and the helical anchor 30 manipulated with the stent mountedreplacement valve 10 in a partially deployed state before the finaldeployment position is reached. FIG. 6A illustrates the helical anchor30 with three coils or turns 32. The top two coils 32 have a relativelysmaller dimension d₂ while the lowest turn or coil 32 has a relativelylarger dimension or diameter d₁. FIG. 7B illustrates a stent mountedreplacement valve 10 with a balloon 140 inside to deploy the valve 10once the valve 10 has been positioned inside the helical anchor 30. Thehelical anchor 30 is placed with two of the coils or turns 32 positionedabove the native mitral valve 12 and one coil or turn 32 positionedbelow the native mitral valve leaflets 12 a, 12 b and adjacent to themitral valve native annulus 12 c. The arrows 142 indicate the radiallyoutward direction of balloon inflation and the resulting expansion ofthe stent mounted replacement heart valve 10.

FIG. 7C illustrates expansion of the balloon 140 and stent mountedreplacement heart valve 10. Since the diameter of the upper two coils orturns 32 of the helical anchor 30 are smaller, as the balloon 140 isexpanded, the stent mounted replacement heart valve 10 first contactsthe smaller turns 32 of the helical anchor 30. The stent mounted heartvalve 10 becomes engaged against these two smaller diameter turns orcoils 32. While in this position, the catheter deploying the balloon 140may be used to manipulate or reposition the helical anchor 30. Themovement of the balloon catheter 140, such as in the direction of thelarge arrow 146, will result in the large turn 32 of the helical anchor30 being moved upwardly toward the native mitral annulus 12 c in thisillustrative example. That is, the turn or coil portion 32 adjacent tothe native mitral annulus 12 c will move in the direction of the smallarrows 148 adjacent thereto. This also results in an upper movement ofthe turns or coil portions 32 above the native mitral valve annulus 12c. In fact, with enough force, once the turn or coil portion 32 belowthe annulus 12 c comes in contact with the leaflet 12 a or 12 b orannulus tissue 12 c below the mitral valve 12, the helical anchor 30 canactually be sprung open such that a segment of the helical anchor 30that connects the turn or coil portion 32 above the leaflet 12 a or 12 band below the leaflet 12 a or 12 b, becomes extended. This can increasethe gap between segments of the helical anchor 30.

FIG. 7D illustrates a stent mounted replacement heart valve 10 fullyexpanded after deployment and expansion by a balloon catheter 140, whichhas been removed. The largest turn or coil 32 of the helical anchor 30is positioned relatively high just under the native mitral annulus 12 c.After full inflation of the balloon catheter 140, the system cannot movebecause the native mitral valve of leaflets 12 a, 12 b are now trappedbetween the helical anchor 30 and the stent mounted replacement heartvalve 10. The balloon catheter 140 that holds the replacement heartvalve 10 may be moved in any direction. In this figure, up and downmotions are clearly possible as these would be made by moving theballoon catheter 140 in and out of the patient. There are manydeflectable catheters which would allow the balloon catheter 140 to movelaterally also.

This series of figures is intended to show how procedures can beconducted with a helical anchor 30. The anchor 30 can be engaged andmanipulated by the stent mounted valve 10 prior to the final positioningand full expansion of the stent valve 10.

It is also possible to manipulate the anchor 30 prior to its release.The anchor 30 can have a catheter or other element attached to it duringthis procedure. So both the anchor 30 and the stent mounted valve 10could be remotely manipulated to achieve a desired result.

FIGS. 7A-7D also show how inflating the balloon 140 inside smaller turns32 of the anchor 30 can serve to “tighten” a larger turn 32. Part of thelarger turn or coil 32 under the annulus 12 c is drawn up above theannulus 12 c when the smaller turn or coil 32 is expanded, thusshortening the coil 32 under the annulus 12 c. This allows the largecoil 32 to tighten around the stent valve 10. This effect is morepronounced when a larger coil 32 is located between two smaller coils 32of the anchor 30. The two small coils 32 on each side of the larger coil32 expand and thus decrease the diameter of the larger coil 32 so thelarger coil 32 can trap and assist in anchoring the valve 10.

It is very important to position the anchor 30 as close to the annulus12 c as possible. This is the natural anatomic location for the valve10. If the anchor 30 is attached to leaflet tissue 12 a, 12 b remotefrom the annulus 12 c, the leaflet tissue 12 a, 12 b moves with eachbeat of the heart. This can cause rocking of the anchor 30 and the valve10. Repeated motion can lead to valve dislodgement. So strategies toallow placement of large coils 32 of the anchor 30 near the annulus 12 care important. It is also useful to convert a larger coil 32 to asmaller coil 32 so that the coil 32 can actually function to trap thestent valve 10.

FIG. 7D-1 illustrates another embodiment of a replacement valve 10 andhelical anchor 30 combination in which the upper end of the replacementvalve 10 does not flare outward but rather is retained in a generallycylindrical shape, for example, by upper coils 32 of the anchor 30. Thelower end or outflow end is flared radially outward as shown. It will beappreciated that structure, such as a seal (not shown) may be includedbetween the stent 24 and the lower coils 32 for both sealing purposes aspreviously described as well as or alternatively to provide a softer,more compliant surface against the native mitral leaflets 12 a, 12 b. Inaddition, it will be appreciated that the upper coils 32 create a gapand do not engage or trap the tissue adjacent the native mitral valve inthe atrium. On the other hand, the lower coils 32 engage tissue justunderneath the native mitral annulus 12 c. The embodiment of replacementvalve 10 shown in FIG. 7D-1 stands in contrast to valves 10 configuredas previously shown, such as in FIGS. 1A and 1B, in which the valveretains a cylindrical shape after implantation and application of ahelical anchor 30, and, for example, that shown in FIG. 7D in which thevalve 10 includes a very slight outwardly directed configuration at thelower or outflow end but does not result in any significant flare.

FIGS. 8A-8D illustrate the use of a balloon catheter 140 to expand ahelical anchor 30 without the presence of a stent mounted replacementheart valve 10. Specifically, FIG. 8A illustrates a helical anchor 30with approximately four coils or turns 32. There are two coils 32 oneach side of a joining segment 32 a which separates them to create agap. Mitral valve native leaflets (not shown) could easily be positionedbetween the coils 32 at the position of the gap created by the joiningsegment 32 a. In this figure, the balloon 140 is beginning to beexpanded as shown by the radially outward directed arrows 150. FIG. 8Billustrates further expansion of the balloon 140 thereby causing thehelical anchor 30 to create an indentation in the balloon 140 around thehelical anchor 30. The balloon 140 on both sides of the helical anchor30 expands further. This results in a force on the turns or coils 32 ofthe helical anchor 30 that moves them together generally shown by thearrows 152. As the balloon 140 is expanded further, as shown in FIG. 8C,the gap between the turns or coils 32, 32 a diminishes and eventuallymay be completely closed such that the two main portions of the helicalanchor 30 are compressed against each other in the direction of theblood flow or central axis of the helical anchor 30 (i.e., along thelength of the balloon 140). FIG. 8D illustrates a cross sectional viewshowing the turns or coils 32, 32 a of the helical anchor 30 compressedtogether. As shown in these figures, the coils 32, 32 a of the helicalanchor 30 may be compressed against each other by inflating a balloon140 inside the helical anchor 30. There does not need to be a joiningsegment 32 a or gap for this to occur. The helical coils 32 would becompressed tightly against each other with or without the gapillustrated in this embodiment.

This compression can serve as a “motor” to allow various functions tooccur. For example, it can be possible to mount pins or fasteners (notshown) to the turns 32, 32 a of the anchor 30 that can be driven andactivated by the inflation of the balloon 140. The pins or fastenerscould be positioned so they pass through the native valve leaflet. Thefasteners could also traverse the native leaflets and move into theanchor 30 on the opposite side of the leaflet. A fabric coating, spongycoating or another receptive material on the anchor 30 would improve theretention of fasteners.

Generally, these methods and devices would allow for areas of the mitralvalve 12 near the annulus 12 c or on the annulus 12 c to be fastened toa helical anchor 30. The fasteners could traverse the valve tissue andengage coils 32 on the one or on both sides of the leaflets. Leaflettrapping by balloon inflation can allow the mitral valve 12 and itsannulus 12 c to be manipulated and to perform therapeutic procedures.For example, the anchor coils 32 once fastened to a valve leaflet 12 a,12 b could be reduced in size to create a purse string effect on thevalve annulus 12 c—resulting in an annular reduction or annuloplastyprocedure. A drawstring (not shown) could be added to the anchor 30 toreduce the diameter.

The fasteners could be used to join segments of the helical anchor 30together. For example, turns or coils 32 of the anchor 30 above theleaflet 12 a, 12 b could be joined together. Fabric or other materialcould be wrapped around or otherwise placed on the anchor coils 32 andpins or fasteners from one coil 32 could engage and trap themselves inthe fabric of an adjacent coil 32. Adjacent coils 32 could engage eachother. This can create a greater mass on each side of the leaflet 12 a,12 b to control the mitral annulus 12 c. In summary, balloon inflationinside a helical anchor 30 can drive coils 32 of the anchor 30 together.This maneuver can be used as a motor or drive mechanism to activatemechanical systems. It can also move anchor coils 32 tightly together.

FIGS. 9A-9D illustrate another ability of the helical anchor 30 as thehelical anchor 30 is expanded by a balloon 140. In this regard, theactual total length of the helical coils 32 forming the anchor 30remains the same. Therefore, to increase the diameter of the helicalanchor 30, the ends 30 a, 30 b of the helical anchor 30 must move toaccommodate the expansion. This movement may also be used as a motor ordrive mechanism to activate additional functions. More specifically,FIG. 9A illustrates a balloon 140 being expanded inside the helicalanchor 30. As the balloon 140 expands, the diameter of the helicalanchor 30 increases and the opposite ends 30 a, 30 b of the helicalanchor move to accommodate the expansion. As shown by the arrows 160,the ends 30 a, 30 b of the coils 32 move or rotate in oppositedirections. FIG. 9B illustrates continuation of the balloon expansionand the previous figures of FIGS. 8A-8D show how the balloon 140 alsocompresses the coils 32 of the helical anchor 30 together. FIG. 9Bhighlights how the coils 32 of the helical anchor 30 rotate generally asthe balloon 140 expands. This rotation is helpful in retaining a stentmounted replacement heart valve as the tension around the stent portionof the heart valve (not shown) increases. FIG. 9C illustrates that thehelical anchor 30 has unwound as it expands under the force of theballoon 140. There are fewer turns or coils 32 and the remaining turnsor coils 32 are now larger in diameter. FIG. 9D shows a cross sectionalview of the expanded helical anchor 30. The motion of the ends 30 a, 30b of the helical anchor 30 can be used to perform functions. As furtherdescribed below, for example, the movement of the coils 32 of thehelical anchor 30 may be used to drive anchors, or perform otherfunctions.

FIGS. 10A-10E illustrate the effect of a cover or coating 170 on thehelical anchor 30. Also, the replacement valve 10 as shown, for example,in FIGS. 10B and 10C, takes on an outward flare at both the upper andlower ends. This may not be desirable for various reasons, but rather,at least one end of the valve 10 may be desired to have and retain agenerally cylindrical cross sectional shape (as viewed from above orbelow). The coating or covering 170 may be in the form of any type ofsheath or material applied to the helical anchor 30 and may be comprisedof any biocompatible material. For example the coating 170 may be madeof fabric material, such as Dacron, Teflon or other material. It may beformed from PTFE or EPTFE in fabric form that has a fabric texture or asa plastic sleeve, or cover or coating that is smooth. There may be afoam material under the coating 170 as is commonly used in, for example,surgical valves. The foam material may consist of rolls of fabric orfolds of fabric. Other possible materials include resilient materialsor, more specifically, material such as medical grade silicone.Biological materials may also be used, and may include animal, human, orbioengineered materials. Some materials commonly used in cardiac repairprocedures are pericardium and intestinal wall materials. FIG. 10Aillustrates a helical anchor 30 which is covered by a coating 170comprised of a fabric backed by a foam material. The helical anchor 30is positioned inside the native mitral heart valve 12 with two turns orcoils 32 above and two turns or coils 32 below the native mitral valveannulus 12 c. A stent mounted replacement heart valve 10 is placedinside of the helical anchor 30 and inflation of the balloon deliverycatheter 140 inside the replacement heart valve 10 has begun asindicated by the arrows 172. In FIG. 10B, the replacement stent mountedvalve 10 is shown fully expanded against the helical anchor 30.Typically, the stent portion 24 of the valve 10 is comprised of thinmetal material that includes openings or cells. These openings or cellsbecome embedded against the coating or covering 170. The stent 24therefore firmly engages with the helical anchor 30 creating a verystrong attachment for the replacement valve 10 inside the helical anchor30. FIG. 10C more specifically illustrates an enlarged viewdemonstrating how the stent portion 24 has deformed the fabric and foamcoating 170 of the helical anchor 30. This engagement is very strong andprevents the replacement heart valve 10 from becoming dislodged. FIG.10C-1 is an even further enlarged view showing a cell or opening 24 a ofthe stent 24 that is engaged against the foam and fabric covering 170,creating a very strong physical connection between these two components.FIG. 10D illustrates a balloon catheter 140 expanding a replacementvalve 10 inside of the coated helical anchor 30 from a view above thehelical anchor 30. FIG. 10E illustrates the same view from above thehelical anchor 30, but illustrating full expansion of the valve 10 afterinflation of the balloon catheter 140 (FIG. 10A). The stent portion 24of the replacement heart valve 10 is then fully engaged into theresilient, frictional coating 170 on the helical anchor 30.

FIGS. 11A-11D illustrate an embodiment that includes a covering orcoating 180 on the helical anchor 30 which is intermittent, as opposedto the continuous coating 170 shown in the previous figures. In thisregard, there are segments of coating 180 along the helical anchor 30and these segments 180 may be rigidly fixed to the helical anchor 30.However, there may also be an advantage to allowing these segments 180to slide along the helical anchor 30 as the helical anchor 30 isexpanded using, for example, balloon inflation as previously described.The segments 180 may slide along the coils 32 of the helical anchor 30to allow the helical anchor 30 to tighten and at the same time thesegments 180 can firmly engage with the cells or openings 24 a of thereplacement heart valve stent 24.

FIG. 11A illustrates a helical anchor 30 with a covering that isintermittent and formed with segments 180. The covering segments 180 areshown with a taper at each end to allow the anchor 30 to be turned intoposition without a flat leading edge to impair placement. The taper isnot necessary, but assists if desired in this regard. This taper may beof any suitable design and may be angular, or curved in any shape thatpromotes easy motion of the helical anchor 30. A balloon catheter 140 ispositioned inside of a stent mounted replacement valve 10 as previouslydescribed and is initiating its inflation as indicated by the arrows182. FIG. 11B illustrates the stent mounted replacement heart valve 10fully expanded. The coating segments 180 have become fully engagedwithin the cells or openings of the heart valve stent 24. Once thesesegments 180 engage with the stent 24 and enter one or more cells oropenings, they become fixed to the stent 24 and they will begin to slidealong the helical anchor 30. The helical anchor 30 can expand andtighten against the stent portion 24 of the replacement valve 10 and atthe same time there will still be the beneficial effect of intermittentand strong attachment to the helical anchor 30 afforded by the segments180 of high friction and resilient and/or compressible material. FIGS.11C and 11D illustrate the process from above the helical anchor 30showing initial expansion of the stent mounted replacement heart valve10 in FIG. 11C and full expansion and engagement between the segments180 and the stent 24 in FIG. 11D firmly attaching these two structurestogether during the implantation procedure within a patient.

FIGS. 12A-12E illustrate a helical anchor 30 and the motor or drivefunction provided when the helical anchor 30 expands and the ends 30 a,30 b of the coils 32 move. FIG. 12A illustrates a helical anchor 30 withabout four turns or coils 32, while FIG. 12B illustrates a helicalanchor 30 with about three turns or coils 32. As further shown in FIG.12B the helical anchor 30 is attached to barbed fasteners 190 fordelivery into a replacement heart valve 10. A fabric or other materialcoating or exterior 192 is applied around the barbs 190 and around thehelical anchor 30. When a balloon 140 is inflated inside of the helicalanchor 30, the two ends 30 a, 30 b of the helical anchor 30 move inopposite directions as the helical anchor 30 is expanded. In thismanner, the barbs 190 are oriented in opposite directions to themovement of the helical anchor 30 so that these barbs 190 will beactivated or move when the helical anchor 30 is expanded. FIG. 12Cillustrates a cross section of the helical anchor 30 with the fabric orother covering or coating 192 and a fastener system 190 coupled with thehelical coil 30. It was previously described as to how the turns orcoils 32 of the helical anchor 30 may be driven together by inflation ofa balloon 140. Balloon inflation also drives or moves the turns 32 ofthe helical anchor 30 together, increasing the penetration of the barbs190. The barbs 190 in FIGS. 12B-12E are oriented obliquely relative tothe central axis of the helical anchor 30, however, the barbs 190 mayinstead deploy in a straight or parallel direction relative to the axisof the helical anchor 30, straight toward an adjacent turn or coil 32 ofthe helical anchor 30, driven by the compression of the helical coils 32together by the inflating balloon 140. With expansion, the ends 30 a, 30b of the helical anchor 30 move considerably, but the central part ofthe anchor 30 does not turn or rotate considerably. Barbs 190 without anoblique orientation may be preferred at the center coils 32. The angleof the barbs 190 may increase and their length can be increased in areastoward the ends 30 a, 30 b of the helical anchor 30 where the movementduring inflation of a balloon 140 is more pronounced. FIG. 12Dillustrates a top view of the helical anchor 30. As the balloon catheter140 is inflated, the helical anchor 30 increases in diameter and theends 30 a, 30 b of the helical anchor 30 rotate to allow this diameterexpansion. As shown in FIG. 12E, the expansion of the helical anchor 30has mobilized or deployed the barbs 190 and the barbs 190 engage intothe fabric or other material coating 192 within the middle or centralturn or coil 32. This locks the turns or coils 32 of the helical anchor30 together. No native valve leaflet tissue is shown in FIG. 12E,however, it will be appreciated that leaflet tissue could be locatedbetween the turns or coils 32 and the barbs 190 could entail and engagethe leaflet tissue for further securing the helical anchor 30 to thenative mitral valve tissue.

FIGS. 13A-13C illustrate another embodiment in which a helical anchor 30is used having relatively larger diameter turns or coils 32 at the endsof the anchor 30 and a relatively smaller turn or turns in a middle orcentral portion of the helical anchor 30. The helical anchor 30 isattached to barbs 190 and covered by a suitable coating material 192,such as fabric or other material. When the balloon 140 is inflated theends of the helical anchor 30 begin to move and the barbs 190 areactivated as the central, smaller helical turn 30 is expanded outwardly.This particular arrangement is ideal to attach to the native mitralvalve of a patient. One barbed turn or coil 32 of the helical anchor 30may be placed above the native mitral valve leaflets and one barbed turnor coil 32 may be placed below the native mitral valve leaflets. Thesmaller diameter turn or coil 32 may sit above or below the nativemitral valve leaflets. When the balloon (not shown) is inflated, thelarge helical turns or coils 32 above and below the native mitral valveleaflets will be driven towards each other as generally shown anddescribed above in FIGS. 8A-8D. Also, the anchor ends will rotate andbarbs 190 will deploy through the mitrel valve leaflet tissue positionedbetween the larger turns or coils 32 close to the native annulus. Thetwo large helical turns or coils 32 can also be bound together as thebarbs 190 cross the mitrel tissue and penetrate the covering 192 on thehelical coil 32 at the opposite side of the native mitral valve. Theseactions will trap the mitrel valve between the turns or coils 32 of thehelical anchor 30, although it is not necessary for this to occur. It isalso apparent that the large diameter turns or coils 32 at the oppositeends of the helical anchor 30 will become smaller in diameter as theballoon is expanded. In this regard, the upper and lower turns or coils32 “donate” to the middle coil or turn 32. This will result in adiameter reduction for the upper and lower coils 32. After the coils 32have been fastened to the native mitral valve perimeter or annulus, thiswill result in a downsizing of the diameter of the mitral valve, i.e.,an annuloplasty procedure will result. When the barbs 190 are retainedin the native mitral valve tissue firmly, they should not dislodge orwithdraw after penetration. FIG. 13C illustrates a cross sectional viewof a helical anchor 30 from FIG. 13B, as well as a barb system 190 andcoating 192, such as fabric or other material. As described previously,barbs 190 can deploy directly from the helical anchor 30 at a roughly90° angle relative to the coil 32. This may be driven simply bycompressing coils 32 relative to one another as described above inconnection with FIGS. 8A-8D. The movement of the helical coil or anchorturns 32 longitudinally or rotationally also allows barbs 190 or othertypes of fasteners to be applied in a direction which is more parallelor oblique relative to the turns or coils 32 of the helical anchor 30.

FIGS. 14A-14C illustrate a different configuration for a helical anchor30. This anchor 30 has generally four coils 32. There are two uppercoils 32 followed by a joining segment 32 a (gap segment). The joiningsegment 32 a is typically used to separate the coils 32 of the anchor 30that sit above the valve leaflets from those that are below (in theatrium and in the ventricle, respectively). There is a coil 32 b ofsimilar size as the two upper coils 32 at the end of the joining segment32 a. This is the lowest coil 32 b on the anchor 30. The final coil 32 cchanges direction—instead of continuing on downward, it coils back upand overlaps or crosses over an adjacent coil 32 of the anchor 30. Thiscoil 32 c is shown as the “larger convolution” in FIG. 14B. The figureshows a directional change (like the joining segment) in the anchor 30that allows the final coil 32 c to be directed upward. The final coil 32c is also larger to allow it to sit on the outside of the other coils.This larger coil 32 c is the middle coil of the anchor 30 but isactually turned into the native valve first when being delivered. Theimportant feature of this anchor 30 is that as it is turned intoposition, the upward bend in the joining segment 32 a forces the anchor30 up toward the annulus. This anchor 30, when positioned with two coilsabove and two coils below the leaflets, sits with the larger coil 32 cof the anchor 30 sitting right under the mitral valve annulus. Theanchor 30 does not tend to fall into the ventricle. The lowest coils donot necessarily have to cross on the same point when viewed from theside (producing an X). They could cross for example on opposite sides.

The key element in the embodiment of FIGS. 14A-14C is for the turning ofthe anchor 30 into position to result in an upward motion of the end ofthe anchor 30 which drives the anchor 30 into position right under themitral valve. As this anchor is “screwed in” the lowest coil 32 b forcesthe anchor 30 upward against the mitral annulus. The larger diametercoil 32 c in the middle of the anchor 30 also helps the anchor 30positioning right under the leaflets and close to the annulus. Themitral annulus has a certain diameter and by matching this diameter withthe diameter of the largest anchor coil 32 c, the anchor 30 is able tosit right under the annulus. If this coil 32 c is too small, the anchor30 can drag against the leaflet tissue and inhibit the anchor 30 fromriding upward toward the annulus as it is placed. It will be appreciatedthat crossing coils 32 a, 32 b in an anchor 30 may also be useful forvalve anchoring when using an anchor 30. The crossing coil 32 a occursin the lowest coil of this anchor 30. But a crossing segment 32 a couldoccur in any location. It could occur at the top, in the middle or atthe bottom of the anchor 30. The amount of crossover could also vary.Here the cross over includes the lowest two coils 32. There could bemore coils that overlap. FIG. 14C shows the overlapping coil 32 a withthe lowest coil being outside the prior coils. The overlapping coil 32 aor crossing segment could occur inside the prior coils. FIG. 14C alsoshows an abrupt change in pitch to cause an overlap. The overlap canalso occur with a gentle change of pitch. In FIGS. 14A through 14C, thespacing between coils in both the top to bottom and side to sidedimensions are exaggerated for clarity. The coils will apply compressionfrom the top and bottom toward the center.

A major advantage of the configuration shown in FIGS. 14A-14C is thatthe number of coils 32 available to attach the valve is increased, butthe length of the anchor 30 does not increase. This allows a shorteranchor. For example, it may be useful to have less anchor lengthpositioned in the left ventricle 40 so the valve 10 can sit more towardsthe atrium 42. The overlapping or crossing coils 32 a may crossover in adesired manner and allow the valve 10 to be retained with strong forceand a shorter overall length inside the left ventricle 40. The overlap32 a in the anchor could also be positioned at the level where thenative leaflets 12 a, 12 b are sitting. This would increase the trappingof the leaflets 12 a, 12 b—the anchor 30 could be positioned such thatoverlapping coils had leaflet between them. If the gap between the coils32 of the anchor 30 were sufficiently small, the leaflets 12 a, 12 bcould be trapped between the coils 32 without the need for additionalfasteners. This arrangement may also position the leaflets 12 a, 12 b tobe fastened to the anchor 30 or an anchoring system attached or guidedby the anchor 30. This particular anchor arrangement is also usefulbecause the lowest coil of the anchor coils 32 extends in the oppositedirection to the remainder of the anchor 30—while the other coils 32 arebiased downward, this is biased upward. As this anchor 30 is turned intoposition, the lowest coil 32 b will tend to move back upward. This isactually creating a virtual reverse thread. A typical helical anchor isscrewed into the valve leaflets 12 a, 12 b like a corkscrew and as it isturned, it moves downward. With this configuration, once the first coilof the anchor 30 is turned into the valve 12 and the joining segment 32a is reached, the anchor 30 actually begins to turn upward instead ofdownward as the lowest coil 32 b is being turned in. This means thisparticular anchor arrangement will tend to sit right under the annulus12. This is useful in optimally positioning the anchor 30 close to theunderside of the annulus 12. An anchor 30 attached to the leaflets 12 a,12 b away from the annulus 12 will tend to move and rock as the heartcontracts. This is because of leaflet motion away from the annulus 12 asthe heart beats. In contrast the annulus 12 itself moves very little asthe heart beats. By placing the anchor 30 closer to the annulus 12 (awayfrom the leaflets), the amount of movement of the anchor 30 is reduced.Each day the heart beats about 100,000 times. This repetitive motionwill produce a risk of anchor and valve dislodgement. Thus minimizingthe motion by placing the anchor 30 close to the annulus 12 will reducethe risk of valve implant failure. In FIGS. 14A-14C, the crossing pointsfor the anchor coils 32 are both on the same side of the anchor 30. Thiscreates an X. It is not necessary for the crossing points to occur atthe same side. For example, they could be on opposite sides of theanchor 30.

While the present invention has been illustrated by a description ofpreferred embodiments and while these embodiments have been described insome detail, it is not the intention of the Applicants to restrict or inany way limit the scope of the appended claims to such detail.Additional advantages and modifications will readily appear to thoseskilled in the art. The various features and concepts of the inventionmay be used alone or in any combination depending on the needs andpreferences of the operator. This has been a description of the presentinvention, along with the preferred methods of practicing the presentinvention as currently known. However, the invention itself should onlybe defined by the appended claims.

What is claimed is:
 1. A system for replacing a native heart valve, thesystem comprising: an expansible helical anchor having at least threecoils in an unconstrained state, wherein a first coil of the helicalanchor has a first diameter in the unconstrained state, and isexpandable to a second diameter larger than the first diameter uponapplication of radial outward force from within the first coil, andwherein the first coil is configured such that it can encircle nativeleaflets of the native heart valve while a second coil does not encirclethe native leaflets; and an expansible heart valve prosthesis capable ofbeing delivered into the helical anchor and expanded inside the firstcoil to move the first coil from the first diameter to the seconddiameter while trapping at least a portion of the native leafletsbetween the first coil and the heart valve prosthesis.
 2. The system ofclaim 1, wherein the helical anchor includes a third coil that movesfrom a larger diameter to a smaller diameter as the heart valveprosthesis is expanded inside the multiple coils.
 3. The system of claim2, wherein at least two adjacent coils of the helical anchor are spacedapart, and the adjacent coils move toward each other as the heart valveprosthesis is expanded inside the first coil.
 4. The system of claim 1,wherein at least two adjacent coils of the helical anchor are spacedapart, and the adjacent coils move toward each other as the heart valveprosthesis is expanded inside the first coil.
 5. The system of claim 1,wherein the helical anchor further comprises a plurality of fasteners,and the fasteners are moved from an undeployed state to a deployed stateas the first coil moves from the first diameter to the second diameter.6. The system of claim 5, further comprising a seal coupled with thehelical anchor and including portions extending between adjacent coilsfor preventing blood leakage through the helical anchor and past theheart valve prosthesis, wherein the fasteners engage the seal in thedeployed state.
 7. The system of claim 1, further comprising at leastone compressible element on the helical anchor, the compressible elementbeing engaged by the heart valve prosthesis as the heart valveprosthesis is expanded inside the first coil to assist with affixing theheart valve prosthesis to the helical anchor.
 8. The system of claim 7,wherein the at least one compressible element further comprises multiplecompressible elements spaced along the helical anchor.
 9. The system ofclaim 7, wherein the at least one compressible element further comprisesa continuous compressible element extending along the helical anchor.10. The system of claim 7, wherein the at least one compressible elementfurther comprises a resilient element.
 11. The system of claim 7,wherein the heart valve prosthesis further comprises an expansiblestructure including openings and the openings are engaged by the atleast one compressible element as the heart valve prosthesis is expandedinside the first coil.
 12. The system of claim 1, wherein the helicalanchor includes at least two coils that cross over each other.
 13. Thesystem of claim 1, wherein the helical anchor further comprises a shapememory material.
 14. The system of claim 1, further comprising a sealcoupled with the helical anchor that includes portions extending betweenadjacent coils.
 15. The system of claim 14, wherein the seal furthercomprises a membrane or panel extending over at least two coils of thehelical anchor.
 16. The system of claim 15, wherein the membrane orpanel is moved between an undeployed state and a deployed state, theundeployed state being adapted for delivery to a site of implantationand the deployed state being adapted for implanting the system andanchoring the heart valve prosthesis.
 17. The system of claim 16,wherein the undeployed state comprises a rolled up state on one of thecoils of the helical anchor.
 18. The system of claim 16, wherein theundeployed state comprises a collapsed state.
 19. The system of claim15, wherein the membrane or panel includes a support element affixedtherewith.
 20. The system of claim 14, wherein the seal furthercomprises one or more seal elements carried by the helical anchor andincluding overlapping portions configured to seal a space betweenadjacent coils of the helical anchor.
 21. The system of claim 20,wherein the one or more seal elements each include a support elementaffixed therewith.
 22. The system of claim 20, wherein the one or moreseal elements are each generally circular in cross sectional shape. 23.The system of claim 20, wherein the one or more seal elements are eachoblong in cross sectional shape.
 24. The system of claim 20, wherein theone or more seal elements each have a connecting portion affixed to oneof the coils and an extension portion extending toward an adjacent coil.25. The system of claim 1, wherein, in the unconstrained state, thefirst coil has a different a radius of curvature than the second coiland a third coil of the helical anchor.
 26. The system of claim 1,wherein, in the unconstrained state, the first coil of the helicalanchor is positioned between the second coil and a lower end coil of thehelical anchor, and wherein the first coil has a smaller radius ofcurvature than the second coil and the lower end coil.
 27. A system forreplacing a native heart valve, comprising: a helical anchor having atleast three coils in a relaxed state, the helical anchor beingimplantable at the native heart valve such that a first coil portion ispositioned above a heart valve annulus and a second coil portion ispositioned below the heart valve annulus such that it encircles nativeleaflets of the native heart valve, wherein, in the relaxed state, thefirst coil portion of the coils has a first radius of curvature that isdifferent from a second radius of curvature of the second coil portion;a cover disposed over at least some of the helical anchor and includinga portion extending between at least two adjacent coils; and aprosthetic heart valve capable of being positioned inside the helicalanchor at the native heart valve and expanded inside the helical anchorsuch that at least a portion of native leaflets of the native heartvalve are trapped between the helical anchor and the prosthetic heartvalve.
 28. The system of claim 27, wherein the second coil portion ispositioned between the first coil portion and a third coil portion, andwherein the second radius of curvature is smaller than the first radiusof curvature and a third radius of curvature of the third coil portion.29. The system of claim 27, wherein the prosthetic heart valve comprisesa seal.
 30. The system of claim 29, wherein the seal of the prostheticheart valve includes a fabric or polymeric covering.
 31. The system ofclaim 29, wherein the seal includes a support element.
 32. The system ofclaim 27, wherein the seal includes overlapping portions configured toseal a space between adjacent coils of the helical anchor.
 33. Thesystem of claim 27, wherein the seal is generally circular in crosssectional shape.
 34. A system for replacing a native heart valve, thesystem comprising: an anchor comprising: a plurality of middle regioncoils in a relaxed state; an upper coil extending from an upper end ofthe plurality of middle region coils; a lower coil extending from alower end of the plurality of middle region coils; wherein, in therelaxed state, at least one of the plurality of middle coils has a firstdiameter and the lower coil has a second diameter that is greater thanthe first diameter; and wherein, upon application of an outward radialforce, the first diameter expands to a third diameter; and a radiallyexpanding replacement heart valve configured to be inserted within theplurality of middle coils; wherein the upper coil is configured toremain in the atrium, and the lower coil is configured to encircle themitral valve leaflets and the chordae in the left ventricle.
 35. Thesystem of claim 34, further comprising a seal structure over at least aportion of the plurality of coils.